NCT01010464

Brief Summary

The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

November 9, 2009

Last Update Submit

April 2, 2020

Conditions

Open Abdomen

Keywords

AdhesionsOpen abdomenLaparotomy

Outcome Measures

Primary Outcomes (1)

  • Extent and severity of adhesions

    Each abdominal re-entry and re-exploration

Secondary Outcomes (2)

  • Time for lysis of adhesions

    Each abdominal re-entry and re-exploration

  • Incidence of complications

    Hospital admission

Study Arms (2)

Adhesion Reduction Plan

EXPERIMENTAL

Lysis of adhesions and application of Seprafilm

Procedure: Adhesion Reduction Plan

Standard Management

NO INTERVENTION

Standard management and no application of Seprafilm

Interventions

Adhesion Reduction PlanPROCEDURE

Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane

Also known as: Seprafilm
Adhesion Reduction Plan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trauma patients with open abdomen after initial laparotomy
  • Emergency surgery patients with open abdomen after initial laparotomy
  • Able to obtain consent from patient or LAR before any research initiated

You may not qualify if:

  • Seprafilm application at initial laparotomy
  • Patient is a prisoner
  • Inability to obtain informed consent
  • Consentable person does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201-1595, United States

Location

MeSH Terms

Conditions

Tissue Adhesions

Interventions

Seprafilm

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William C. Chiu, M.D.

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 10, 2009

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

US(1)